# K093738: Mri Patient Positioning Devices

- Pathway: 510(k) (Traditional)
- Applicant: Medtec, Inc.
- Decided: May 14, 2010 after 161 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K905007 (1991). 14 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950866: Hip Fixation System, Medtec, Inc. (1995) Summary page 1.
- K080072: Mri Patient Positioning Devices, CIVCO Medical Instruments Co., Inc. (2008) Summary page 1.
- K060737: Sinmed Positioning Devices, Sinmed BV (2006) Summary page 1.
- K973842: Carbon Fiber Conformal Couch Top, Medtec, Inc. (1997) Summary page 1.

## Most influential descendants
- K111340: Head and Neck Immobilization System, Body Immobilization System (2011), 13 descendants of its own
- K142420: Patient Positioning Devices (2015), 7 descendants of its own
- K122888: CDR Systems Precision Patient Positioning System (2013), 5 descendants of its own
- K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement (2016), 3 descendants of its own
- K212909: VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips (2022), 2 descendants of its own

## Indications for use
Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.

Source page: https://510kreport.com/device/K093738
Methodology: https://510kreport.com/methodology